Siponimod, a selective sphingosine 1-phosphate receptor modulator, appears to be generally safe and effective for the reduction of disability progression in secondary progressive multiple sclerosis (SPMS).1

Previous research demonstrated reduced brain lesion counts and annualized relapse rates in patients with relapsing-remitting MS treated with siponimod.2 The current phase 3 study examined the effects of siponimod in 1645 patients with SPMS. Patients were randomly assigned to receive either once-daily siponimod 2 mg (n=1099) or placebo (n=546) for up to 3 years or until confirmed disability progression. The primary end point was time to 3-month confirmed disability progression, and secondary end points included time to 3-month confirmed worsening of ≥20% from baseline in the timed 25-foot walk test and change from baseline in T2 lesion volume.

At baseline, mean time from MS symptom onset was 16.8 years, and mean time from conversion to SPMS was 3.8 years. Time since last relapse was >2 years in 64% of patients, and 56% required assistance with ambulation.

Ultimately, 82% of patients randomly assigned to siponimod and 78% assigned to placebo completed the study. Of patients in the siponimod group, 26% had 3-month confirmed disability progression compared with 32% of patients in the placebo group (hazard ratio [HR] 0.79; 95% CI, 0.65-0.95; relative risk reduction 21%; P =.013). The risk for 6-month confirmed disability progression was also reduced in the siponimod group (risk reduction 26%). Adjusted mean increase across all visits in the 12-item Multiple Sclerosis Walking Scale was 2.69 in the siponimod group vs 4.46 in placebo. In addition, annualized relapse rate (rate ratio 0.45; 95% CI, 0.34-0.59; risk reduction 55%; P <.0001) and time to confirmed first relapse were also reduced in the treatment group (HR 0.54; 95% CI, 0.41-0.70; risk reduction 46%; P <.0001), as well as increase in T2 lesion volume, decrease in brain volume, and gadolinium-enhancing lesions.

Related...

The health and medical information on our website is not intended to take the place of advice or treatment from health care professionals. It is also not intended to substitute for the users’ relationships with their own health care/pharmaceutical providers.